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Atrial FibrillationHPvSP-AFNCT04250181

High Power vs Standard Power RF Ablation of Atrial Fibrillation in Conscious Patients

An observational study of Atrial Fibrillation, run by Medical University of Lublin at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

High RF energy ablation of atrial fibrillation is fast, safe, less painful and effective procedure. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
RF ablation of atrial fibrillation
How many people
30 participants
Where
1 sitePoland
Study dates
15 Nov 2019to 8 Feb 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with atrial fibrillation

Who may be able to join

  • symptomatic patients with non-valvular AF,
  • aged:18-85, first procedure in left atrium,
  • exclusion of thrombus in left atrium and left atrium appendage,
  • left ventricle ejection fraction >55%

Who cannot join

  • age below 18 or above 85 years,
  • left ventricle ejection fraction<55%,
  • previous procedure in left atrium,
  • valvular AF

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Medical University of Lublin

    Lublin, 20-091

Other trials in Poland

About this study

Official title: HPvSP-AF Trail: Is High RF Energy Ablation of Atrial Fibrillation Fast, Safe, Less Painful and Effective - a Propensity Score Matched Analysis of 30/25W, 40W and 50W RF Energy Settings

High RF energy ablation of atrial fibrillation is fast, safe, less painful and effective procedure.

Read the detailed description

Atrial fibrillation (AF) ablation is the most commonly performed radiofrequency (RF) ablation and is usually associated with a long procedural time and sensation of pain in conscious patients. Prolonged radiation exposure during the procedure puts the patient and the operator at risk of malignancy and genetic abnormalities. Complications such as asymptomatic cerebral lesions, tamponade, perforation, and also arrhythmia recurrence were associated with longer ablation time.

High-power, shorter-duration radiofrequency ablation (HPSDRFA) appears to be a novel concept for atrial fibrillation (AF) but there are scarce data in conscious patients. The lesion side index (LSI) value has been associated with durability of pulmonary vein isolation (PVI) lesions.

We hypothesised that HPSDRFA applications based on the lesion side index (LSI; its has been associated with durability of pulmonary vein isolation (PVI) lesions) which were not inferior to standard approach regarding safety and effectiveness with shorten procedure time and being less painful for a patient.

Being tested
RF ablation of atrial fibrillation
Keywords
atrial fibrillation ablation, high power radiofrequency ablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RF ablation of atrial fibrillationOther

    Comparison of standard, 40W and 50W RF energy setting for ablation of atrial fibrillation

Study groups in NCT04250181
Study groupRoleWhat they receive
Standard RFablation with RF power of 30 Watts (30W) and with 25 Watts (25W) on posterior wall
Receives: Other: RF ablation of atrial fibrillation
High RF 40W (40 Watts)ablation with RF power of 40 watts (40W)
Receives: Other: RF ablation of atrial fibrillation
High RF 50W (50 Watts)ablation with RF power of 50 watts (50W)
Receives: Other: RF ablation of atrial fibrillation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Procedure time:

    Total procedure time (needle to needle time).

    Measured: procedure

Secondary outcomes (8)

  1. Left atrial dwelling time

    time of left atrium instrumentation

    Measured: transeptal access to removal of a catheter and a sheath

  2. Voltage mapping time

    time needed to perform 3D electroanatomical map and high density voltage mapping of left atrium.

    Measured: procedure

  3. Total RF time

    time of all performed radiofrequency (RF) applications

    Measured: procedure

  4. Total number of RF applications

    number of all RF applications performed during a procedure

    Measured: procedure

  5. X-Ray time

    the total time of fluoroscopy

    Measured: procedure

  6. Complications

    both procedure-related complications and all complications in 12 moths follow-up as follows: Cardiac tamponade/perforation [yes/no], Stroke/TIA (Transient ischemic attack) [yes/no], Oesophageal injury (perforation/fistula) [yes/no], Death (procedural related, one year follow up) [yes/no], Stem pops [yes/no], Catheter char [yes/no], Phrenic nerve paralysis [yes/no], PV stenosis requiring intervention [yes/no], Gastrointestinal bleeding or gastrointestinal complaints [yes/no], Need for periprocedural pacemaker implantation [yes/no], Vascular access complication which required intervention [yes/no], Vascular access complication which not required intervention [yes/no],

    Measured: 12 months

  7. Number of stopped RF applications as a result of pain complained by a patient

    the surrogate for assessment of the painfulness of the procedure

    Measured: procedure

  8. Follow-up-30s

    absence any arrhythmia recurrence (AR) defined as any documented recurrence of AF and/or atrial tachycardia (AT) and /or atrial flutter (AFL) lasting longer than 30 second

    Measured: procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2020
  2. Study start15 Nov 2019
  3. Primary completion20 Jan 2020
  4. Study completion8 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04250181
Sponsor's protocol ID
HPvSP-AF ablation
Acronym
HPvSP-AF
Status last verified
Feb 2020
First submitted
29 Jan 2020
Last updated
18 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design. Europace. 2012 Apr;14(4):528-606. doi: 10.1093/europace/eus027. Epub 2012 Mar 1. No abstract available.

    PubMed 22389422

  • Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Alexandru Popescu B, Schotten U, Van Putte B, Vardas P. 2016 ESC Guidelines for the Management of Atrial Fibrillation Developed in Collaboration With EACTS. Rev Esp Cardiol (Engl Ed). 2017 Jan;70(1):50. doi: 10.1016/j.rec.2016.11.033. No abstract available. English, Spanish.

    PubMed 28038729

  • Galeazzi M, Ficili S, Dottori S, Elian MA, Pasceri V, Venditti F, Russo M, Lavalle C, Pandozi A, Pandozi C, Santini M. Pain perception during esophageal warming due to radiofrequency catheter ablation in the left atrium. J Interv Card Electrophysiol. 2010 Mar;27(2):109-15. doi: 10.1007/s10840-009-9447-y. Epub 2009 Nov 27.

    PubMed 19943098

  • Aryana A, Heist EK, D'Avila A, Holmvang G, Chevalier J, Ruskin JN, Mansour MC. Pain and anatomical locations of radiofrequency ablation as predictors of esophageal temperature rise during pulmonary vein isolation. J Cardiovasc Electrophysiol. 2008 Jan;19(1):32-8. doi: 10.1111/j.1540-8167.2007.00975.x. Epub 2007 Sep 24.

    PubMed 17900251

  • Patel PJ, Padanilam BJ. High-power short-duration ablation: Better, safer, and faster? J Cardiovasc Electrophysiol. 2018 Nov;29(11):1576-1577. doi: 10.1111/jce.13749. Epub 2018 Oct 25. No abstract available.

    PubMed 30357991

  • Winkle RA, Mohanty S, Patrawala RA, Mead RH, Kong MH, Engel G, Salcedo J, Trivedi CG, Gianni C, Jais P, Natale A, Day JD. Low complication rates using high power (45-50 W) for short duration for atrial fibrillation ablations. Heart Rhythm. 2019 Feb;16(2):165-169. doi: 10.1016/j.hrthm.2018.11.031.

    PubMed 30712645

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Medical University of Lublin at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedure time: (time frame: procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04250181, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.

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